INTERNATIONAL BIOLOGICAL STANDARDS
83
M.47
MEMORANDUM ON
THE REPLACEMENT OF THE SUBSTANCE OF THE
INTERNATIONAL STANDARD FOR MALE HORMONES:
ANDROSTERONE
Prepared by
The Department of Biological Standards,
National Institute for Medical Research,
Hampstead, London, N.W.3.
At the Second International Conference on the Standardisation of Sex Hormones, held
in London in July 1935, under the auspices of the Permanent Commission on Biological
Standardisation of the Health Organisation of the League of Nations, it was decided to
adopt an international standard of male hormone activity. Although the Conference
recognised that androsterone was probably not the primary male hormone as elaborated
by the testis itself, it was considered that this substance would be a suitable standard
of reference, and it was decided that the proposed international standard for male hormone
activity should consist of a pure crystalline preparation of artificially prepared androsterone
with the following characters:
M.P. 183-5° to 184-5° (corrected)
20
[ a] q + 97-3° in absolute alcohol
The National Institute for Medical Research was to act on behalf of the Health Organi¬
sation of the League of Nations to keep the standard and to distribute it to national
control centres.
A total of 10-17 g. of androsterone satisfying the requirements was obtained by pooling
material from four contributors. This material was dispensed into ampoules each con¬
taining about 50 mg. and prepared for distribution. During 1939 the standard became
exhausted and a canvass among members of the 1935 Conference showed a general
opinion that the androsterone standard was useful and should be maintained. Arrange¬
ments were accordingly made for the renewal of the standard. Much delay was occasioned
by the outbreak of war, but a generous gift of 30 g. of androsterone by Dr. Miescher on
behalf of Ciba of Basle, has enabled the standard to be renewed on an adequate scale.
Preparation of the Second International Standard
The melting point and specific rotation of the androsterone provided for the establish¬
ment of the Second International Standard was determined and found to be:
M.P. 182° to 183° (corrected)
20
[ a] ^ + 96 • 5 (c = 1 • 06 in absolute ethyl alcohol)
The preparation, therefore, conforms to the requirements laid down at the Second Inter¬
national Conference on the Standardisation of Sex Hormones and may be accepted a«
suitable for adoption as the Second International Standard for Male Hormone.
The whole of the material provided for the Second International Standard (30 g.) was
distributed, in approximately 50 mg. quantities, into small dry tubes. The tubes were
placed in vacuo over phosphorus pentoxide for some weeks, sample tubes being weighed
at intervals until an assurance was obtained that the weight was constant and accordingly
the standard material was completely dry. The tubes were then filled with pure dry
nitrogen gas and sealed.
The sealed tubes containing the standard were then transferred to cold storage and
are there maintained constantly at a temperature of — 2° C. to — 4° C.